Landauer recalls Calibrate (80 kVp) nanoDot D2DNS dosimeters with specific model numbers due to potential accuracy issues in radiation monitoring. Affected units may not measure radiation exposure correctly.
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
Landauer is recalling Calibrate (80 kVp) nanoDot D2DNS radiation dosimeters with model numbers 04217-000, 04217-KIT, and 04217-SET. These devices may not measure radiation exposure accurately, which could lead to incorrect safety assessments in medical settings.
The dosimeters may have a non-conformance in the Optical Stimulated Luminescence (OSL) material, causing potential inaccuracies in radiation exposure measurements. This could lead to incorrect safety assessments if used in medical imaging procedures.
Medical professionals using radiation dosimeters for medical imaging may be affected. Those who rely on these devices for accurate radiation measurements are at higher risk.
Check for model numbers 04217-000 (EMEA number VINLNAN003), 04217-KIT, or 04217-SET on the device. These are radiation monitoring dosimeters used with microSTAR readers.
Identify if your device has model numbers 04217-000 (EMEA number VINLNAN003), 04217-KIT, or 04217-SET.
Landauer received reports that some nanoDots may be outside the specified accuracy range of +/-5.5%. Investigation found a potential non-conformance in the OSL material.
Model numbers 04217-000 (EMEA number VINLNAN003), 04217-KIT, and 04217-SET are affected.
Inaccurate radiation measurements could lead to incorrect safety assessments in medical imaging procedures.
We’ve drafted a message you can send Landauer to request your refund or repair — edit it as you like.
Subject: Recall Z-2557-2023 — Landauer Landauer Hello, I own a Landauer that is covered by recall Z-2557-2023 from Landauer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
